NCT00668837

A 52 Week Open-label Extension Trial Following the Double-blind Efficacy and Safety Study R076477-SCH-305.

Open Label Extension to R076477-SCH-305 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Open-Label Extension to the double-blind effectiveness and safety study R076477-SCH-305 to evaluate long-term safety and tolerability in patients with schizophrenia.

Detailed description

The primary objective of the open-label extension trial was the long-term assessment of safety and tolerability of flexibly-dosed ER OROS paliperidone (3 to 15 mg/day) in patients with a diagnosis of schizophrenia. Other measures assessed in the extension study included: change in the total Positive and Negative Syndrome Scale (PANSS) score; change in PANSS subscale (positive and negative) scores; overall functioning, as measured by the Clinical Global Impression Scale-Severity (CGI-S); personal and social functioning, as measured by the Personal and Social Performance Scale (PSP); and quality of life parameters, as measured by the Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4). Paliperidone ER OROS® tablet formulation (3 to 15 mg/day) to be taken orally for 52 weeks

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone

Timeline

• Start date: 2004-02-01
• Completion: 2006-06-01
• First posted: 2008-04-29
• Last updated: 2011-06-08